FDA IMPORT RULES AND REGULATIONS
FOOD AND DRUG ADMINISTRATION AND U.S. CUSTOMS COMPLIANCE

As Customs lawyers we find that the FDA is often a highly problematic agency for importers. Very commonly, Customs Penalty or Customs Seizure actions result from failure to comply with FDA import rules.

Our experience includes permitting Grey Market imports, FDA device and/or manufacturer registration, halting importation of Unregistered knock-offs, canceling penalties for failure make goods available for FDA examination, Bioterrorism counseling, and settlement of other U.S. Customs law penalties issued in relation to FDA regulated imports.

The Bioterrorism Act of 2002 introduced an entirely new set of obligations on importers and their commodities subject to FDA regulation. Call our Customs Attorneys if you have any needs in this area, and:

• FDA Imports Home page
• The Bioterrorism Act of 2002   The statute as signed into law on June 12, 2002.
• The Final Rule on Registration The interim final rule as published by FDA on October 10, 2003.
• FDA's Bioterrorism Resources FDA page full of news and resources on The Bioterrorism Act and regulations.
• FDA Prior Notice Website

OTHER FDA RESOURCES

• The FDA home page

Downloadable FDA Forms

• FDA Device Advice web page
  Where you can determine if your items is a regulated "Medical Device"

RECENT FDA ANNOUNCEMENTS

UPDATED May 2008

"IMPORT FOR EXPORT" RULES OUTLINED ON WEBSITE

The FDA Export Reform and Enhancement Act of 1996 ("Export Reform Act"), amended the law to allow the importation of certain articles whicih are unapproved or otherwise do not comply with the Act, provided that those imported articles are further processed or incorporated into products that will be exported from the United States, by their initial owner or consignee  Guidance to FDA branches is made public for your information HERE.

BILL PLANNED TO ALLOW PERSONAL PRESCRIPTION IMPORTS

U.S. Rep. Rahm Emanuel (D-Ill.) said Democrats and Republicans in both chambers will push again for a bill that would allow prescription drugs to be imported to help reduce costs for U.S. consumers. The bill would allow consumers to import drugs directly from Canada, while wholesalers and pharmacies could import FDA-approved drugs from the European Union, Canada, New Zealand, Australia and Japan to sell.

IMPORT REFUSAL LIST AVAILABLE

A fascinating monthly list of refused goods is available online at the FDA website.  Helpful to prospective importers because it shows supplier names and products, it also indicates the many reasons why goods might be refused entry to the United States.  In the most recent listing there is among the refused items:

a) legitimate, but unregistered, Lipitor from Ireland;

b) poisonous caramel from Russia; and

c) peanut butter candy from Argentina lacking English language labeling. 

To see and learn from the complete list click HERE.

IMPORT DRUG BAN MAY EASE

Americans could buy and carry home prescription drugs from Canada under new proposed terms to legislaton agreed upon on September 21, 2006. Customs agents would be prohibited, as part of a Homeland Security spending bill, from seizing as much as a 90-day supplies of prescribed medicines brought across the border by individuals personally. Purchasing cheaper prescriptions over the Internet or by mail-order from Canadian pharmacies would still be prohibited, officials said. Canadian prices for many popular brand-name prescription drugs are 30 percent to 80 percent lower than in the United States, according to surveys by The Associated Press and others. The agreement was announced on the same day that Wal-Mart Stores Inc. announced it plans to slash prices for generic prescriptions to $4.00.

While importing drugs into the United States is illegal, the Food and Drug Administration generally has not stopped small amounts of medicine purchased for personal use. However, Customs officials last November began intercepting prescription drugs coming across the border. Since then, CBP agents have seized more than 34,000 packages of drugs coming into the country.

GUIDANCE FOR INTIAL IMPORTERS

The FDA website provides certain information for new Importers, all of whom must register first. An initial importer (or initial distributor)is the entity which takes first title to the devices imported into the U.S. and distributes the product. Initial importers are required to register. However, they are NOT required to list the products that they import on form FDA 2892.

Wholesale distributors of devices, who do not manufacture, repackage, process, or relabel a device, are not required to register their establishment with the FDA. A "wholesale distributor" is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. More information is available

More information is available here.

MANDATORY BEEF COUNTRY-OF-ORIGIN LABELING DELAYED UNTIL SEPTEMBER 2008

The Congress (through Committee) has agreed to delay the provision requiring mandatory country-of-origin labeling on beef, lamb, pork and other meat products until late-2008.

The meat country-of-origin labeling provision was originally enacted in 2002, but the President has delayed implementation twice. The U.S. cattle industry wants country-of-origin labels to help sell their beef to U.S. consumers who might prefer to "buy American". However, the meatpacking and grocery industries have pressed for repeal of the labeling program because of what they allege are unjustified costs. Many U.S. trading partners have opposed the labeling on grounds that it is actually a trade barrier disguised as a consumer protection matter.

FDA Import Alerts Available on One Page

The Food and Drug Administration has set up a page on its website with searchable Import Alerts covering most of the last decade.  Searches can be performed by Country of Origin, Industry, Date of Original Notice, Date of any update, or Import Alert number.   These detailed Alerts may provide you with notice of forthcoming enforcement actions, or help explain reasons for detention or inspection to you.   The information is available by clicking here.

FDA Extends Pilot Program for Evaluation of Globally Harmonized Medical Device Premarket Applications Until July 2006 (The STED Initiative)

The Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), reminds device manufacturers that its pilot program for submitting premarket applications (premarket notifications (510(k)s) and premarket approval applications (PMAs)) will accept submissions in this format until July 2006.

Under this program, FDA permits manufacturers to submit 510(k)s and PMAs in a Summary Technical Document (STED) format. The STED format is a harmonized submission format developed by the Global Harmonization Task Force (GHTF), a voluntary partnership of government and industry representatives from the United States of America and four other member states. GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.  For more information on this extension click HERE

FDA and CBP Announce revised Compliance Policy Guidelines for imported food

Summary of Entry Changes

CBP will continue to reject PN submissions unless a manufacturer registration number is provided with an Affirmation of Compliance (AOFC) code and reason code is transmitted.

FDA will reject PN submissions made under the Prior Notice System Interface (PNSI) that contain a manufacturer registration number that is not on file or mismatched. FDA will also reject PN submissions received that contain a "FME" AOFC code if the reason code qualifier is invalid. Six new reason codes have been added to indicate why a registration number has not been transmitted.

Customs Informs on FDA Bioterrorism Act Procedures

Customs has published an updated fact sheet, entitled "Frequently Asked Questions & Answers Regarding CBP Procedures under the Bioterrorism Act (BTA)." It includes general information and FAQs regarding Customs' enforcement of the U.S. Food and Drug Administration's prior notice requirements for food imported under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

CBP has also issued other fact sheets and guidance documents regarding implementation of the prior notice and food facility registration requirements under the Bioterrorism Act. These updated guidance documents can be found here:

FDA Issues Updated GuidanceRegarding Registration of Food Facilities

FDA issued the fourth edition of its Web-based guidance for industry entitled "Questions and Answers Regarding Registration of Food Facilities." The fourth edition includes answers to new inquiries regarding the implementation of the FDA's Registration of Food Facilities Interim Final Rule (21 CFR Part 1, Subpart H), published on October 10, 2003. See 68 Fed. Reg. 58,894 Oct. 10, 2003 FDA's interim final regulation was issued to implement the Bioterrorism Act's requirement that domestic and foreign facilities which "manufacture, process, pack, or hold" food for human or animal consumption in the United States must register by December 12, 2003. The updated guidance document can be found here:

The Mooney Law Firm • (850) 893 0670 (800) 583 0250•
Fax (850) 391 4228

nmooney (at) customscourt.com

With Affiliated Customs, International Trade, and FDA Lawyers In All Principal Ports

Copyright © 1999-2008  The Mooney Law Firm All Rights Reserved